FDA OKs NephroCheck to Assess Risk for Acute Kidney Injury

Disclosures

September 05, 2014

The US Food and Drug Administration (FDA) today approved the first laboratory test to assess the risk of hospitalized, critically ill patients developing moderate to severe acute kidney injury (AKI), a condition often diagnosed after it is too late to prevent possible permanent kidney damage and death.

The new test, called NephroCheck (Astute Medical), spots telltale proteins associated with AKI, once known as acute renal injury.

AKI is an abrupt drop in kidney function that can be triggered by everything from heart failure to sepsis. It occurs in up to two thirds of patients in hospital intensive care units, and especially in patients who are elderly, diabetic, or hypertensive. These patients' prospects for long-term survival after AKI in the intensive care unit are poor. A study published earlier this year in PLoS Medicine reported a mortality rate of 62% for such patients after a median of 42.4 months after randomization.

Traditional laboratory tests catch AKI after the fact, and the results often do not come in until after the condition has progressed to a moderate or severe stage, the FDA said in a news release.

In contrast, NephroCheck works as an early-warning system, identifying in the urine the presence of 2 proteins (insulin-like growth-factor binding protein 7 and tissue inhibitor of metalloproteinases) that are linked with AKI. Within 20 minutes, the test scores a patient's risk of developing AKI within the next 12 hours, with the score correlating to the amount of the 2 proteins found.

The FDA judged NephroCheck to be effective and safe on the basis of 2 clinical trials comparing the clinical diagnoses of more than 500 critically ill subjects with results from the new test. In 1 test, NephroCheck identified 92% of patients with AKI. The accuracy rate in the other test was 76%. However, NephroCheck reported false-positives in roughly 1 in 2 patients without AKI in both tests.

More information on today's announcement is available on the FDA's Web site.

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